PMA P050016S005

Device: CORMET HIP RESURFACING SYSTEM
Applicant: Corin USA
PMA number: P050016
Supplement: S005
Product code: NXT
Decision date: 2009-12-03
Classification: Prosthesis, Hip, Semi-constrained, Metal/metal, Resurfacing
Generic name: Prosthesis, hip, semi-constrained, metal/metal, resurfacing
Approval order statement: APPROVAL FOR LABELING CHANGES TO THE PACKAGE INSERT AND PATIENT BROCHURE TO INCLUDE TWO ADDITIONAL POTENTIAL ADVERSE EFFECTS, PSEUDOTUMOURS AND AVASCULAR LYMPHOCYTE DOMINATED VASCULITIS ASSOCIATED LESIONS (ALVAL) AS WELL AS AN ADDITIONAL PRECAUTION THAT THE SUBJECT DEVICE HAS NOT BEEN TESTED IN THE MAGNETIC RESONANCE (MR) ENVIRONMENT.

Current openFDA PMA Record#

Device: CORMET HIP RESURFACING SYSTEM
Applicant: Corin USA
PMA number: P050016
Supplement: S005
Product code: NXT
Generic name: Prosthesis, hip, semi-constrained, metal/metal, resurfacing
Decision date: 2009-12-03
Decision code: APPR
Date received: 2009-11-02
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR LABELING CHANGES TO THE PACKAGE INSERT AND PATIENT BROCHURE TO INCLUDE TWO ADDITIONAL POTENTIAL ADVERSE EFFECTS, PSEUDOTUMOURS AND AVASCULAR LYMPHOCYTE DOMINATED VASCULITIS ASSOCIATED LESIONS (ALVAL) AS WELL AS AN ADDITIONAL PRECAUTION THAT THE SUBJECT DEVICE HAS NOT BEEN TESTED IN THE MAGNETIC RESONANCE (MR) ENVIRONMENT.